Enanta Pharmaceuticals - Q1 2023
February 7, 2023
Transcript
Operator (participant)
Good afternoon, and welcome to Enanta Pharmaceuticals Fiscal First Quarter ended December 31st, 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there'll be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I'd now like to hand the conference over to Jennifer Viera, Investor Relations. Please go ahead.
Jennifer Viera (Executive Director of Investor Relations and Corporate Communications)
Thank you, Operator. Thanks to everyone for joining us this afternoon. The news release with our Fiscal First Quarter 2023 Financial Results was issued this afternoon and is available on our website. On the call today are Dr. Jay Luly, President and Chief Executive Officer, Paul Mellett, our Chief Financial Officer, and other members of Enanta's senior management team. Before we begin with our formal remarks, we want to remind you that we will be making forward-looking statements, which may include our plans and expectations with respect to our research and development pipeline and financial projections, all of which involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ materially from those statements. A description of these risks is in our most recent Form 10-K and other periodic reports filed with the SEC.
Enanta does not undertake any obligation to update any forward-looking statements made during this call. I'd now like to turn the call over to Dr. Jay Luly, President and CEO. Jay?
Jay Luly (President and CEO)
Thank you, Jennifer. Good afternoon, everyone. At Enanta, our mission continues to be to leverage our expertise in small molecule drugs to discover and develop groundbreaking medicines. Our fiscal first quarter of 2023 set up a strong data-rich year, positioning us to potentially drive value for our company as we advance our expanding pipeline. Today, I will start by detailing recent advances in our COVID-19 program, then comment on our broad respiratory syncytial virus, or RSV program, as well as touch base on the rest of our pipeline. Beginning with our COVID-19 program, our lead asset is EDP-235, a clinical-stage once-daily orally dosed inhibitor of the coronavirus 3CL protease, which is currently being evaluated in an ongoing phase II study known as SPRINT. We are pleased to announce that the study has completed enrollment beyond the initial target.
As a reminder, SPRINT is a randomized double-blind, placebo-controlled phase II clinical trial of EDP-235 in approximately 200 non-hospitalized symptomatic adults with mild or moderate COVID-19 who were treated orally with 200 mg or 400 mg or placebo once daily for five days. SPRINT was designed to select a dose to move forward in development by evaluating the primary endpoint of safety and tolerability and key secondary objectives, including virologic endpoints and pharmacokinetics. Clinical symptoms and other clinical outcomes such as rebound will also be evaluated in more of an exploratory manner. We anticipate reporting top line data from this study in May. Based on the study design and previous clinical data demonstrated in our phase I study for EDP-235, we aim to achieve good safety, tolerability, and pharmacokinetics to support once daily dosing.
While this study is not powered on any virologic measurement, we will be looking for trends in antiviral activity as well. As COVID-19 persists and variants that circumvent immunity continue to arise globally, we are encouraged that EDP-235 has demonstrated potent antiviral activity across all SARS-CoV-2 variants tested in vitro to date. We believe EDP-235 has potential to be conveniently prescribed and to treat a broader patient population as EDP-235 does not require ritonavir boosting with its associated drug-drug interactions. If supported by phase II results, we plan to advance EDP-235 to a phase III trial in the second half of this year.
Beyond the positive phase I results of EDP-235, we are also encouraged by the new positive preclinical in vivo data in a ferret model that we presented last month, which continues to add to the strong body of evidence supporting the potential of EDP-235. Findings of this study highlighted the robust antiviral treatment effect as the animals treated with EDP-235 had a rapid and sustained decline in viral load. Further results showed the ability of EDP-235 to prevent the transmission of COVID-19. When healthy animals were moved into housing with infected animals that were treated with EDP-235, they did not contract COVID-19. In contrast, when healthy animals were moved into housing with infected animals treated only with vehicle, they did become infected with COVID-19.
We look forward to presenting the detailed findings of our phase I study for EDP-235, the results of our ferret model study, and two other preclinical posters at the International Conference on Antiviral Research, or ICAR, in March, along with preclinical data at the European Congress of Clinical Microbiology and Infectious Diseases, or ECCMID, in April. Beyond EDP-235, we announced a new research program to develop inhibitors for SARS-CoV-2 papain-like protease, or PLpro. We believe the addition of this program gives us multiple opportunities to combat COVID-19, that potentially these programs may work together. PLpro is another essential enzyme which plays an important role in viral replication, and in addition, acts to blunt the innate immune response. Inhibition of PLpro blocks viral replication and has the potential to alleviate the suppression of the immune response to SARS-CoV-2 infection.
As this mechanism is distinct from 3CL protease inhibition, has the potential to be used alone or in combination with 3CL protease inhibitors such as EDP-235 or other compounds to provide a range of treatment regimens for different patient populations suffering from COVID-19. Our prototype inhibitors demonstrate nanomolar potency against the Omicron variant in both biochemical and cellular assays, and we continue to optimize inhibitors as we progress this program forward toward development candidate selection. Continuing with our industry-leading respiratory virology treatment portfolio, we're progressing our broad RSV program, which includes EDP-938, the most advanced N-protein inhibitor in clinical development, as well as EDP-323, our novel oral therapeutic targeting RSV L-Protein RNA polymerase. Our goal is to develop an effective therapeutic for RSV that provides a cure for the populations that are severely affected by this virus.
EDP-938 is being evaluated in multiple phase II clinical studies, including RSV-HR, phase IIB study in adults with acute RSV infection who are at high risk of complications, including the elderly and/or those with congestive heart failure, COPD, or asthma. RSV-Peds, a phase II study in hospitalized and non-hospitalized pediatric RSV patients, and RSV-Tx, phase IIB study in adult hematopoietic cell transplant recipients with acute RSV infection and symptoms of upper respiratory tract infection. These three studies are expected to continue through 2023. We'll continue to monitor the RSV epidemiology to evaluate the impact on trial enrollment and timing for these data readouts. Also in RSV, last quarter we announced a dosing of the first subject in the phase I study of our L-Protein Inhibitor, EDP-323.
This ongoing double-blind, placebo-controlled first-in-human study is designed to enroll approximately 80 healthy subjects to evaluate the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323. We believe both EDP-938 and EDP-323 could serve as standalone treatments or be used in combination regimens to broaden the treatment window or addressable patient populations for RSV. We look forward to presenting preclinical pharmacokinetic data on EDP-323 at ECCMID and expect to report top-line phase I data next quarter. Moving on to our respiratory discovery program, we're excited to recently announce our novel broader spectrum antiviral research program targeting both RSV and human metapneumovirus, or hMPV, with a single agent. HMPV and RSV are similar viruses. Both are important causes of respiratory tract infections and are endemic globally, impacting several vulnerable populations, including children, the elderly, adults with underlying cardiopulmonary disease, and those who are immune-compromised.
We're encouraged by preclinical findings in which our prototype dual inhibitor demonstrated potent nanomolar activity against multiple genotypes and strains of both viruses in a range of cell types. Further, our prototype dual inhibitor potently inhibited replication of both hMPV and RSV in a dose-dependent manner in respective mouse models, demonstrating a significant reduction in viral load of both viruses. A dual inhibitor provides the potential for a broader spectrum antiviral that would allow respiratory infections diagnosed as either hMPV or RSV to be treated with a single agent. We continue to optimize our potent dual inhibitor and aim to select a clinical candidate in the fourth quarter of this year.
Turning to hepatitis B, we are cognizant of the continued high unmet need for this disease as it is a global public health threat and the world's most common serious liver infection, making it the primary cause of liver cancer. We are focused on identifying different mechanisms of action and alternative compounds to develop in combination with EDP-514, our potent core inhibitor, and an existing nucleoside reverse transcriptase inhibitor, which we believe can ultimately be important components of a successful combination regimen. Finally, I'd like to wrap up by highlighting our near-term milestones. Again, we are thrilled with the progress of EDP-235 for the treatment of COVID-19 and plan to announce top-line data from phase IIB study SPRINT in May, and pending results, initiate a phase III study in the second half of this year.
We plan to report top-line data from our phase I study of EDP-323, our RSV-L inhibitor, next quarter. We look forward to presenting data on our RSV and COVID programs at the ICAR in March and ECCMID in April. With that, I'll turn the call over to Paul to discuss our financials. Paul?
Paul Mellett (CFO)
Thank you, Jay. For the quarter, total revenue was $23.6 million and consisted primarily of $22.6 million of royalty revenue earned on AbbVie's global MAVYRET net product sales. This compares to total revenue of $27.6 million for the same period in 2021. The decline is primarily a result of continued lower treated patient volumes due to the COVID pandemic. Royalty revenue was calculated on 50% of MAVYRET sales at a royalty rate for the quarter of 12% after adjustments for certain contractual discounts, which are now approximately 2% of AbbVie's total reported HCV product sales. You can review our royalty schedule in our 2022 Form 10-K.
Moving on to our expenses, for the three months ended December 31, 2022, research and development expenses totaled $40.9 million, compared to $48.5 million for the same period in 2021. The decrease was primarily due to the timing of drug supply manufacturing and preclinical studies in the company's virology program year-over-year. General and administrative expense for the quarter was $12.7 million, compared to $9.5 million for the same period in 2021. This increase was primarily due to an increase in headcount and related stock-based compensation expense.
Net loss for the three months ended December 31, 2022 was $29 million or a loss of $1.39 per diluted common share, compared to a net loss of $30.1 million or a loss of $1.48 per diluted common share for the corresponding period in 2021. Enanta ended the quarter with approximately $241.4 million in cash and marketable securities. We expect that our current cash equivalents, and short-term and long-term marketable securities, as well as our ongoing royalty revenue, will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs into the fourth fiscal quarter of 2024. Further financial details are available in our press release and will be available in our quarterly report on Form 10-Q when filed.
I'd now like to turn the call back to the operator and open up the lines for questions. Operator?
Operator (participant)
Thank you, sir. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again, and please stand by while we compile the Q&A roster. We ask that you keep your questions to no more than one, but please feel free to go back into the queue, and if time permits, we'll be more than happy to take your follow-up questions at that time. I show our first question comes from the line of Joe Kim from RBC Capital Markets. Please go ahead.
Joe Kim (AVP)
Hi, this is Joe, on for Brian. Thank you for taking my question. I just wanted to quickly ask on your latest view on the COVID outlook and what sort of, you know, evolving market opportunity you're seeing in COVID. That's my question. Thank you.
Jay Luly (President and CEO)
Sure. Thank you. This is Jay. Regarding the outlook, you know, it's been certainly a rough few years in terms of the pandemic, and I think there's a migration to the endemic phase of this. We see it as a tremendous opportunity that will probably, you know, ultimately settle down to be something more than flu. Obviously, there's several different angles you can think about playing with a product like EDP-235 over the longer term. You can think about high-risk patient populations. You can think about standard risk patient populations. You can also think about possibilities in long COVID and also from a post-exposure prophylaxis perspective. All of these are potential avenues to build over time and, you know, to grow.
We don't see this virus going away anytime soon, if ever, and that it's likely to persist in a very meaningful way in a public health perspective.
Joe Kim (AVP)
Thank you.
Jay Luly (President and CEO)
You're welcome.
Operator (participant)
I show our next question comes from the line of Yasmeen Rahimi from Piper Sandler.
Emma Nesson (AVP of Biotech Equity Research)
Hi, this is Emma on for Yas. Thanks for taking our questions. We are wondering that based on your market research, how cumbersome is the ritonavir boost for Paxlovid, and what is the appetite among physicians for EDP-235 adoption? Thank you.
Jay Luly (President and CEO)
I think, you know, ritonavir is definitely not a desirable. You know, ultimately, it adds complexity. You're trying to treat a respiratory virus with a respiratory viral drug, a protease inhibitor, and you're adding an HIV protease inhibitor just to boost the drug levels in the case of Paxlovid. It's really the boosting agent that, you know, leads to many drug-drug interactions as it relates to ritonavir. Ritonavir also has a taste problem and Paxlovid as it's currently being administered is three pills in the morning, three pills in the later part of the day, and then four or five days. It's 30 pills in total.
you know, the doses that we're selecting in our SPRINT study for evaluation, either of those, we believe can ultimately be formulated into a single tablet, which could be one pill once a day based on the pharmacokinetics that we've observed in phase one healthy clinical trials. you know, if we can achieve one pill once a day with a very potent and effective drug and not have a boosting agent that leads to lots of drug-drug interactions and complexities for physicians, that's an attractive product profile, everywhere we've checked.
Operator (participant)
Yeah. Let me compile our next question. I show next question comes from the line of Brian Skorney from Baird. Please go ahead.
Luke Herrmann (Senior Biotechnology Research Associate)
Hi, this is Luke on for Brian. Since SPRINT excludes elevated risk patients, would you have to do any additional safety work before going into a pivotal in a higher risk setting?
Jay Luly (President and CEO)
Not, not necessarily. I think, you know, certainly Pfizer went from phase I healthies into a high risk. I recognize that was at an earlier time. You know, we're currently in discussions with regulatory agencies, but at this time, there's no reason to suspect a different safety profile of the drug in that patient population.
Operator (participant)
Next question. Thank you. I show next question comes from the line of Roanna Ruiz from SVB Securities. Please go ahead.
Roanna Ruiz (Senior Managing Director and Senior Biotechnology Analyst)
Hi. Thanks for taking the question. Maybe tagging on to some of the COVID questions. I was curious about your new PLpro mechanism antiviral. How do you expect that to fit into the treatment landscape in the future, especially when it's possible there could be multiple 3CL protease inhibitors available, assuming they get approved?
Jay Luly (President and CEO)
Sure. Thanks, Roanna. I think, you know, Enanta, when we go after a virus, we usually don't sit tight with one mechanism, especially when it's a new virus that no one has approved drugs for. When we started working early on in the pandemic, we went after multiple mechanisms, including 3CLpro and PLpro. 3CLpro, you know, gave rise to our first candidate sooner than PLpro. At the end of the day, no one's really had the opportunity to study a PLpro in clinical trials. Whereas there may be multiple 3CLpros across the line, ultimately, again, we think the best product profile will win longer term. We also wonder out loud, you know, could a PLpro have other advantages over a 3CLpro.
We know that 3 PLpro, like 3CLpro, is a critical enzyme in viral replication. Either protease inhibitor should be able to knock down the replication part of it. PLpro also has a role in blunting the innate immune response of the host. We wonder if there couldn't be some extra impact that you could have in a treatment by having a PLpro inhibitor that not only shuts down replication, but may also, you know, block the suppression of that innate immune response. In this sort of a situation, more drug choices are better than fewer. We don't believe at this time that there's any reason to believe that combination on top of a 3CLpro is necessary, but that might not always be the case.
There may be special patient populations where you'll wanna have two drugs to try to help the person rather than just one. For all these reasons, and especially where we are in fully understanding this virus, it's good to have multiple shots on goal. We think the PLpro is really interesting. We've got some great chemical matter, we're pushing as hard as we can to bring that forward as a candidate.
Operator (participant)
Thank you. I show next question comes from the line of Akash Tewari from Jefferies. Please go ahead.
Amy Li (SVP of Biotechnology Equity Research)
Hi, this is Amy on for Akash. Thanks so much for taking our question. On the SPRINT trial, I know you indicated that, it's not powered to show viral load reduction, but, would love to kind of hear any sort of color on what it is powered to show in terms of symptoms benefit or any other endpoint that you think is relevant. What are you specifically looking for in the data in order to move forward? Additionally, what are the big inflection points in your view where you're looking to partner out the program ideally? Thanks so much.
Jay Luly (President and CEO)
I think all this sort of hangs together. I, you know, the primary endpoint, as we've disclosed previously, is safety and tolerability. It was not powered on these other parameters. It certainly wasn't powered on a symptomatic readout. Nonetheless, these are things that you look at as secondary endpoints to gather as much information as you can in terms of what factors, you know, what symptoms might have been modulated the most, in with this current variant that, you know, the drug was tested against. This is all important information to capture as you're planning phase III. We'll also be looking for trends in viral loads to help us select a dose.
Typically with these protease inhibitors, you know, you see, you know, maybe about a log. You don't see profound viral load drops the way these things are measured in these studies. Nonetheless, with a trial that's roughly around 200 patients, we did over-enroll the study. But I think, you know, hopefully it's set up to give us what we need to know about safety and tolerability between doses, look for trends in the virology between the doses, and anything else we can get out of this study is gravy, so to speak, as we're, as we're planning phase III studies. This, this data is obviously, you know, what we're trying to achieve in the SPRINT data.
You indicated, you know, questions about, you know, what's appropriate for a partner. You know, partners always have what they wanna see, but suffice it to say, you know, the data package that we're putting together continues to build into something that's very interesting and perhaps, best in class.
Operator (participant)
Thank you. I show our next question comes from the line of Matthew Hershenhorn from Oppenheimer. Please go ahead.
Matthew Hershenhorn (Equity Research Associate)
Hey, this is Matt, on for Jay Olson as well. Thank you so much for taking our questions. We were wondering, for the hMPV RSV dual inhibitor, could you just talk about the potential utilization in the real world? How common, for example, is it for patients to have a co-infection? Also, how will the dual inhibitor impact EDP-938 and EDP-323 development? Really appreciate it. Thank you.
Jay Luly (President and CEO)
Sure. Thanks for the question. So the dual inhibitor, to be clear, we're not looking for co-infected patients. Although they could exist, I think that would be a relatively rare thing. It might be more common to be infected with COVID and RSV or COVID and human metapneumovirus, but even that co-infection in these specific instances is probably rather rare. Instead, the way we're thinking about it is more of a broad spectrum antiviral, one that we could use to treat either infection so that regardless of whether it was RSV or human metapneumovirus, in the diagnosis, you could just use one drug to take care of both of them.
RSV, you know, is also a virus that most pediatricians can tell an RSV infection just based on, you know, bronchiolitis and other sorts of symptoms. You know, someday it might even be used to treat patients presumptively for those infections. Having the comfort that you could treat either RSV or human metapneumovirus would be a great advantage. I'll kinda go back to my earlier point. When we get into an area, we don't usually just pick on one mechanism for a drug or one drug class. We like coming forward really understanding, especially in an area like RSV and human metapneumovirus, where there are no approved drugs. We wanna have as many different mechanisms and classes that we can bring forward.
Ultimately, you know, there will be, you know, comparative data that we'll have. We may elect to select them into different patient populations. In some instances, there may be reasons to do combinations. You didn't ask about our L-Protein Inhibitor for RSV-323, but that's another mechanism that we have in addition to EDP-938. We have a lot of optionality going forward.
Operator (participant)
Thank you. I show our next question comes from the line of Ed Arce from H.C. Wainwright & Co. Please go ahead.
Ed Arce (Senior Research Analyst)
Hi, Jay. Thanks for taking our questions. Really just one on EDP-323, in RSV, with data in second quarter, as you mentioned. Just wondering, this study is obviously in human volunteers, so there's really no opportunity yet for virological data. I'm just wondering what kind of, what criteria are you looking at? How should we judge this early, safety and PK study result? How would you judge it to move forward?
You know, as you think about next steps, when do you think we could get, initial efficacy data? Thanks.
Jay Luly (President and CEO)
Thanks, Ed. So EDP-323 data in Q2. It's, you know, it's a standard phase I in healthy trial, but the good news is when it comes to virals, that tells you an awful lot and can, in fact, do a lot of de-risking of the asset, as you know. So we'll be looking at safety PK, especially PK. Not that safety is unimportant, but PK is where you really dial in your dose selection for future studies. There, we always aim, you know, for once daily dosing. That's always our target. We hope to achieve once daily dosing that gives adequate trough level concentrations at the 24-hour time point to deliver good pressure on the virus in terms of multiples of the EC90.
If we can do all of that, and that's certainly what we've done with, you know, our other antivirals. Our preclinical modeling, you know, suggests that we've picked doses to achieve that in this study. We'll soon enough know the answer to that. Assuming that the data are good, you know, you can think about, you know, probably the quickest way to get antiviral data would be to do a challenge study, which you can also use to, you know, check antiviral effect. You can look at symptoms, and you can also further refine any dose decisions that you might be wanting to make for other more advanced studies. I think that's the broad layout for the year.
Operator (participant)
Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. I show our next question comes from the line of Eric Joseph from JPMorgan. Please go ahead.
Eric Joseph (Executive Director of Biotech Equity Research)
Good evening. Thanks for taking the questions. Just a couple on EDP-235 in COVID-19. I'm wondering if there's a clear sense of the types of endpoints that would be needed to support registration for a COVID-19 antiviral, just given where we are with vaccine exposure and prior virus exposure. Has there been any shift, I guess, from the precedent set by Paxlovid and Lagevrio? Then secondly, assuming compelling data from SPRINT, I just wanna get a sense of the sequencing of events from here between partnering and launching the phase III study. I guess specifically whether your cash guidance through fourth quarter next year anticipates full execution of a phase III trial, whether you could go it alone. Thanks for taking the questions.
Jay Luly (President and CEO)
I think we're setting ourselves up to, you know, collect SPRINT data, assuming it's as expected, having discussions with the regulators to design that phase III study. There's lots of different possibilities in terms of how you could think about that in terms of endpoints. Maybe I'll let Tara Kieffer here elaborate on that a little bit further. But with regards to, you know, partnering, you know, That timing will be that timing, and I'm not gonna, you know, commingle that with SPRINT phase III start or data collection. We'll give updates on each of those tracks, you know, as updates are relevant. From a cash perspective, we would position ourselves to be able to do that ourselves.
Obviously, it depends a lot on what phase III development plan you choose and how that, those, phase III designs are ultimately implemented in terms of trial size, et cetera. Right now, I think we feel reasonably good about that. Maybe I'll turn the call off to Dr. Tara Kieffer here. She's our Senior Vice President of New Product Strategy and Development, who's been thinking a lot about phase III stuff along with our clinical team, about possible endpoints and so forth. Again, we will ultimately select it after discussions with the agency. Nothing that we're gonna declare today, but there's different possibilities. Tara?
Tara Kieffer (SVP of New Product Strategy and Development)
Sure. Thanks, Jay. Hi, Eric. Thanks for the question. This is Tara. I think, you know, if you think about phase III trials for COVID, there's a number of different strategies that one could think about, including different patient populations. A high-risk patient population, standard risk population. There are currently phase III studies going on in both of those populations, also ones that have mixed populations. In terms of endpoints, there are studies looking at hospitalization and death. Obviously, the rates are lower than what they were at the peak of the pandemic with different variants coming along now. You know, some of the strategies being used would include high-risk patients that really focus in on those that have a higher risk and really elevating that event rate. You know, other endpoints that are being used are looking at symptoms.
Shionogi has an ongoing phase III trial now that's looking at a symptom endpoint. They have shown data from their other phase III trials being run in Asia, where they did see a significant effect on symptoms, looking at a subset of five symptoms that were shown in phase IIB study to be more correlated with an effect. I think there's a number of different strategies one can use. We're obviously thinking about all of those among others and having discussions with regulatory agencies, you know, as we move forward to our next phase.
Operator (participant)
Thank you. I show our next question comes from the line of Roy Buchanan from JMP Securities. Please go ahead.
Roy Buchanan (Equity Research Analyst)
Hey, thanks for taking the question. I guess, one on EDP-514. Doesn't sound like it. Maybe more concretely, are you shifting to look more externally or internally versus your prior expectations, I guess, for partnering candidates? I'm just thinking J&J's comments around their hepatitis B program, GSK going into phase III with just an ASO and a nuke. Any change to your thinking? Thanks.
Jay Luly (President and CEO)
No change to the thinking. I think core inhibitors are still an impactful class of HBV drug. I think ultimately, you know, whereas we're doing a little bit internally, we're looking externally at the landscape for other possible options. But I also think it's important while we're in sort of this phase to be thinking about other data sets that are gonna be ultimately coming from others, which may inform, you know, potential other combination ingredients. I would say we're not in a hurry to push something ahead just to do it. We're being very thoughtful and disciplined on this front.
Until or unless we've come up with that solution, you know, we're not gonna just push a dual acting regimen forward in clinical development and spend that money and manpower on it. I think it's gonna be a little bit more watching and analyzing and a little bit of doing.
Operator (participant)
Yeah. I show our next question comes from the line of Akash Tewari from Jefferies. Please go ahead.
Amy Li (SVP of Biotechnology Equity Research)
Hi, this is Amy again. Thanks so much for taking our follow-up. Just wanted to get your thoughts on, Pfizer recently made some interesting comments that competitor COVID antivirals won't be on the market until around 2025, and they could show worse efficacy because of the lower event rates. Would love to get your thoughts on these comments.
Jay Luly (President and CEO)
You know, Anything is possible. I think Paxlovid today, if you put it in a clinical trial, would show probably a lower event rate as well. You again, you can never know how to speculate on that. I think the, you know, the variants continue to change. I think people will be looking at different things. At the end of the day, we think you can show clinical significance in important patient populations and with an easier-to-use drug that doesn't have some of the liabilities I mentioned earlier on the call. Either way, I think there's gonna be room for other drugs out there that are more conveniently dosed.
Operator (participant)
Yeah. I show our next question comes from the line of Brian Skorney from Baird. Please go ahead.
Luke Herrmann (Senior Biotechnology Research Associate)
Hey, this is Luke again. Just one more for us. On SPRINT criteria, is there any reason to expect meaningfully different antiviral or clinical impact in patients treated after five days of symptoms as opposed to someone who goes in and gets treated on day one? Is that a cross-section you'll look at when you cut the data?
Jay Luly (President and CEO)
We'll have a little bit of a cut in terms of timing on that. I think it's less than three days versus greater than three days up to five days. You know, we'll see what we see. In general, almost always the earlier you treat is, you know, more optimal. COVID has been a little bit more forgiving than some other viruses. We'll just wait and see. We'll collect the data and look at it. Again, that'll help inform how we, how we progress.
Operator (participant)
Thank you. I do show we have another question from Roy Buchanan from JMP Securities. Please go ahead.
Roy Buchanan (Equity Research Analyst)
Hey, thanks for taking the follow-up. Jay, you mentioned some, combo trials that you're tracking, data readouts that are coming up. Can you tell us what those are?
Jay Luly (President and CEO)
Maybe I'll turn that over to Tara. You're talking about in HBV again?
Roy Buchanan (Equity Research Analyst)
Yes. Thanks.
Tara Kieffer (SVP of New Product Strategy and Development)
Sure, Roy. Hi, it's Tara. We'll certainly be looking at all the combination studies that are going on out there today. That would include Roche's larger trial that is looking at combinations that they have with their siRNA and immune modulators. Vir Biotechnology is running a number of trials now with their siRNA as well as looking at therapeutic vaccines. They're also doing a trial with their monoclonal antibody combination and also one with interferon. And then they're additionally looking at one with a TLR8, that's in combination with Gilead. Arbutus Biopharma has a couple of ongoing. They have an siRNA in combination with interferon, so we'll be looking at that trial as well. GSK obviously is moving forward with their ASO alone and in combination with interferon.
We'll be curious to see readouts for all of these trials.
Operator (participant)
Thank you. That concludes our Q&A session. I show no further questions at this time. I'd like to call back over to Jennifer Viera for closing remarks.
Jennifer Viera (Executive Director of Investor Relations and Corporate Communications)
Thank you, Operator, and thanks to everyone for joining us today. If you have additional questions, feel free to contact us by email or call us at the office. Thanks, and have a good night. Bye-bye.
Operator (participant)
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.